The FDA has approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based influenza vaccine, for use in adults 50 and older.
The FDA has approved mFLUSIVA (mRNA-1010), Moderna's mRNA-based influenza vaccine, for adults 50 years and older. Moderna expects supply to be available at select retailers ahead of the 2026–2027 respiratory virus season.
"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said Stéphane Bancel, chief executive officer of Moderna, in the press release. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors."1
The approval reflects a broader commercial milestone as well. mFLUSIVA becomes the company's fifth globally approved product and fourth to receive FDA clearance, alongside Spikevax, mRESVIA and mNEXSPIKE.
The approval for adults 50 through 64 years was based on a randomized, observer-blind, active-controlled Phase 3 trial (NCT06602024) enrolling 40,805 adults across 11 countries. The study compared a single dose of mFLUSIVA against a licensed standard-dose influenza vaccine, with co-primary endpoints of safety and relative vaccine efficacy against RT-PCR-confirmed influenza-like illness caused by any influenza A or B strain.
mFLUSIVA demonstrated a relative vaccine efficacy of 26.6% (95% CI: 16.7%, 35.4%) versus the standard-dose comparator, meeting the study's pre-specified superiority criterion.1 Among adults 65 years of age and older, relative vaccine efficacy reached 27.4%. The safety profile was consistent with prior mFLUSIVA studies.
Solicited adverse reactions—primarily injection site pain, fatigue, headache and myalgia—were mostly mild to moderate and resolved within one to two days, with no new safety signals identified.
Approval for adults 65 and older was granted under accelerated approval, based on immunogenicity data from a separate randomized trial (NCT05827978) enrolling 2,992 adults in the United States, comparing mFLUSIVA against a high-dose inactivated influenza vaccine. As is standard for accelerated approval, a confirmatory postmarketing trial is required to verify clinical benefit in this population.
Influenza continues to impose an outsized burden on older adults. Adults 65 and older accounted for approximately 57% of influenza-related hospitalizations and 71% of influenza-related deaths in the United States during the 2024–2025 season, according to Centers for Disease Control and Prevention data.2 A systematic review found hospitalization rates of roughly 309 per 100,000 in this age group across 15 flu seasons, with modeling data suggesting 71% to 85% of all influenza-related deaths occur in adults 65 and older.3
Standard-dose influenza vaccines have long been the foundation of seasonal prevention, though immune responses wane with age and effectiveness can vary considerably by season. High-dose and adjuvanted formulations emerged to address this gap, but mRNA technology represents a distinct mechanism: lipid nanoparticle-encapsulated messenger RNA instructs cells to produce hemagglutinin proteins that prime immune responses, potentially enabling faster antigen optimization when circulating strains shift.
mFLUSIVA enters a market already served by established high-dose and adjuvanted flu vaccines targeting older adults. The approval follows a unanimous recommendation from the FDA Vaccines and Related Biological Products Advisory Committee supporting use in adults 50 and older, which is a signal of regulatory confidence in the product's benefit-risk profile.4
Regulatory submissions for mFLUSIVA have been accepted for review in the European Union, Canada and Australia, with additional country submissions planned during 2026.
The accelerated approval pathway for adults 65 and older means clinical benefit in this highest-risk group must still be confirmed through postmarketing study. Additionally, reactogenicity, while manageable and consistent with other mRNA vaccines, was more frequent with mFLUSIVA than with comparators, a consideration for real-world uptake among older patients managing multiple chronic conditions.
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